Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
tga
Reporting Medicine Shortages AND Discontinued Supply Australia
tga
Understanding Listed Medicines Compliance Reviews
tga
Manufacturing OR Supplying House Vitro Diagnostic Medical Devices Ivds
tga
Applying NEW Inhalation OR Nasal Spray Medicines OR Changing Existing Medicines
tga
Using Modified Unprocessed Herbal Materials Complementary Medicines
tga
Applying Provisional Registration Extension OR Transition Full Registration
tga
Complying Quality Requirements Medicinal Cannabis
tga
Supporting Claims AND Indications Listed Medicines
tga
Dossier Requirements Class 2 3 AND 4 Biologicals
tga
Applying Provisional Registration Prescription Medicine
tga
Using Literature Based Submissions Listed Assessed Listed AND Registered Complementary Medicines
tga
Manufacturing Sunscreen AND Complying Good Manufacturing Practice GMP
tga
Supplying Overseas Medicines When Australian Medicines ARE Unavailable OR Short Supply
tga
Releasing Medicines Manufactured Multiple Sites Good Manufacturing Practice GMP
tga
Evaluating Seasonal Influenza Vitro Diagnostic IVD Self Tests Clinical Performance AND Risk Mitigation
tga
Clinical Performance Evaluation AND Risk Management Seasonal Influenza Rapid Antigen Tests
tga
Variations Prescription Medicines Excluding Variations Requiring Evaluation Clinical OR Bioequivalence Data Process Guidance
tga
Registering Additional Trade Names Prescription Medicines
tga
Using Software Covid 19 Rapid Antigen Self Tests
tga
Supplying Unapproved Therapeutic Goods Sponsor
tga
Permitted Indications Listed Medicines
tga
Making Offer Enforceable Undertaking Compliance
tga
Submitting Risk Management Plans Medicines AND Biologicals
tga
Advertising Mushroom Products ARE Therapeutic Goods
tga
Over Counter OTC Medicine Monograph Guaifenesin
tga
Over Counter OTC Medicine Monograph Laxatives Docusate Sodium Andor Sennosides
tga
OTC Medicines Safety AND Efficacy Data
tga
Reclassifying Active Medical Devices Therapy Diagnostic Functions
tga
Over Counter OTC Medicine Monograph Loperamide Hydrochloride
tga
Reporting Shortage OR Discontinuation Medicine YOU Supply
tga
Pharmacovigilance Responsibilities Medicine Sponsors
tga
Explaining Data Protection Scheme Assessed Listed Medicine
tga
Preparing Application Audit Vitro Diagnostic Medical Devices
tga
Understanding Your Post Market Responsibilities Biologicals
tga
Complying Regulatory Requirements System OR Procedure Packs
tga
Understanding Minimal Manipulation Method Preparation Biologicals
tga
Understanding OUR Pharmacovigilance Inspection Program Pvip Medicines
tga
Preparing Good Clinical Practice GCP Inspections
tga
Over Counter OTC Medicine Monograph Paracetamol Oral USE
tga
Demonstrating Safety Adventitious Agents
tga
Meeting Eligibility Criteria Priority Determination Applications Biologicals
tga
Over Counter OTC Medicine Monograph Topical Imidazole Antifungals Dermal USE Clotrimazole AND Miconazole Nitrate
tga
Understanding Legislative Framework Listed Medicines
tga
Understanding Quality Requirements Listed Medicines
tga
Complying Release Supply Medicines RFS Rules Good Manufacturing Practice GMP
tga
Reclassifying Medical Devices Administer Medicines OR Biologicals Inhalation
tga
Understanding Timeframes Comparable Overseas Bodies Process Registered Complementary Medicines Assessed Listed Medicines AND Substances Listed Medicines
tga
Exporting Medicines Australia
tga
Over Counter OTC Medicine Monograph Topical Nasal Decongestants
tga
Using Comparable Overseas Bodies Process Registered Complementary Medicines Assessed Listed Medicines AND Substances Listed Medicines
tga
Over Counter OTC Medicine Monograph Bromhexine Hydrochloride
tga
Creating Prescription Medicine Labels Meet Requirements
tga
Scheduling Handbook Guidance Amending Poisons Standard
tga
Including Vitro Diagnostic IVD Medical Devices Artg
tga
CTD Modules 2 3 4 AND 5 Registered Complementary Medicine Applications
tga
Understanding Evidence Requirements Market Authorisation Medical Devices
tga
Applying Export Certification Medical Devices
tga
Understanding Your Obligations Borderline Disinfectant Products Antiviral Claims
tga
Understanding Application Requirements Microorganisms Listed OR Registered Complementary Medicine
tga
Clinical Evidence Guidelines Medical Devices
tga
Variations Prescription Medicines Excluding Variations Requiring Evaluation Clinical OR Bioequivalence Data Chemical Entities
tga
Variations Prescription Medicines Excluding Variations Requiring Evaluation Clinical OR Bioequivalence Data Biological Medicines
tga
Labelling Medicines Comply TGO 91 AND TGO 92
tga
TGA Approved Terminology Therapeutic Goods
tga
Complying Advertising Rules Therapeutic Goods When Making ASX Announcement
tga
Prescription Medicines Registration Process
tga
Understanding Good Manufacturing Practice GMP Registered Medicinal Gases
tga
Understanding Serialisation AND Data Matrix Codes Medicines
tga
Good Manufacturing Practice GMP Requirements Medicinal Products Pics Guide GMP Pe009 17
tga
Argom Appendix 2 Guidelines Quality Aspects OTC Applications
tga
Argom Appendix 5 Guidelines OTC Applications Specific Substances
tga
Understanding Standards Face Masks AND Respirators
tga
Meeting Microbiological Standards NON Prescription AND Prescription Medicines
tga
Providing Patient Information Leaflets AND Implant Cards Medical Devices
tga
Reclassifying Medical Devices ARE Substances Introduced Body OR Applied Skin
tga
CTD Module 1 Administrative Information AND Prescribing Information Australia
tga
Using Global Medical Device Nomenclature Gmdn Terms Medical Devices
tga
Understanding Conformity Assessment Vitro Diagnostic Medical Devices Ivds 0
tga
Submitting Drug Master Files AND Certificates Suitability Drug Substances
tga
Demonstrating Evidence Comply Essential Principles
tga
Understanding Requirements Prescription Medicines Produced Genetic Manipulation
tga
Complying Requirements Relating Impurities Prescription Medicines
tga
Understanding Fees AND Charges Prescription Medicine Applications
tga
Reclassifying Medical Devices Direct Contact Heart Central Circulatory AND Nervous Systems
tga
Using Permissible Ingredients Determination Listed AND Assessed Listed Medicines
tga
Understanding Personalised Medical Devices Rules Including 3D Printed Devices
tga
Understanding Regulatory Basics Medical Devices Health Practitioners
tga
Changing Sponsor Therapeutic Good
tga
Registering Biosimilar Medicine Australian Register Therapeutic Goods Artg
tga
Demonstrating Quality Listed Probiotic Medicines
tga
Varying Biological Entries Artg
tga
Understanding Biologicals Priority Applicant Determination
tga
Understanding Process Submitting Priority Inclusion Application
tga
Applying Inclusion Class 2 3 OR 4 Biological Australian Register Therapeutic Goods Artg
tga
Preparing Your Biologicals Application Inclusion Australian Register Therapeutic Goods Artg
tga
Determining IF Your Content Advertising
tga
Applying Advertising Code Rules Testimonials AND Endorsements
tga
Understanding Requirements Medical Devices Containing Medicinal Microbial Recombinant OR Animal Origin Substances
tga
Advertising Requirements Disease Education Activities
tga
Complying Unique Device Identification Requirements Medical Devices
tga
Complying Unique Device Identification Timeframes Medical Devices
tga
Ensuring Compliance After Removing Product Information Insert
tga
Understanding Labelling AND Presentation Requirements Listed Medicines
tga
Mandatory Requirements Assessed Listed Medicine Application Pass Preliminary Assessment
tga
Mandatory Requirements Effective Application Vary Permissible Ingredients Determination
tga
Mandatory Requirements Effective Over Counter Medicines Application
tga
Mandatory Requirements Effective Registered Complementary Medicine Application
tga
General Dossier Requirements
tga
Biovigilance Responsibilities Sponsors Biologicals
tga
CTD Module 1 Administrative Information Registered Complementary Medicines
tga
CTD Module 1 Administrative Information Assessed Listed Medicines
tga
Common Technical Document Module 1 OTC Medicines
tga
Mandatory Requirements Effective Application
tga
Instructions Disinfectant Testing
tga
Notifications Process Requests Vary Registered Medicines Where Quality Safety AND Efficacy ARE NOT Affected
tga
Understanding Specified Articles AND Excluded Products Personalised Medical Devices Regulation
tga
Understanding Regulation Therapeutic Sunscreens
tga
Understanding Common Technical Document CTD
tga
Exporting Human Substances
tga
Understanding Requirements Dental Practitioners When Making AND Adapting Personalised Medical Devices
tga
Introduction Poisons Standard
tga
Understanding Regulation Listed Disinfectants Australia
tga
Understanding Listed AND Registered Complementary Medicine Regulation
tga
Complying Changes Permissible Ingredients Determination
tga
Reporting Medical Device Adverse Events Healthcare Facilities
tga
Understanding Selection Criteria Medical Device Application Audits
tga
Understanding Medical Device Application Audit Process
tga
Supplying Therapeutic Vapes Pharmacies
tga
Understanding Health Facility Management Software Exclusion
tga
Understanding Communications Software Exclusion
tga
Understanding General Health OR Wellness Software Exclusion
tga
Understanding Image Storage AND Transmission Software Exclusion
tga
Making Over Counter OTC NEW Medicine N1 Applications
tga
Advertising Software Based Medical Devices Australia
tga
Understanding Clinical Workflow Management Software Exclusion
tga
Understanding Electronic Health Records Software Exclusion
tga
Understanding Middleware Health Systems Exclusion
tga
Understanding Calculator Software Exclusion
tga
Understanding Population Based Analytics Software Exclusion
tga
Understanding Laboratory Information Management Software Exclusion
tga
Determining Application Level Umbrella Branded Over Counter OTC Medicines
tga
Understanding When Health Alert Software Systems Qualify Exclusion
tga
Understanding Requirements Over Counter OTC NEW Medicine N2 Applications
tga
Understanding Health Self Management Software Exclusion
tga
Understanding Behavioural Change OR Coaching Software Exclusion
tga
Understanding Patient Survey Software Exclusion
tga
Understanding Digital Mental Health Tool Software Conditional Exclusion
tga
Manufacturing AND Supplying Surgical Loan Kits Australian Hospitals
tga
USE Legislative Powers Related Recalls AND Other Market Actions
tga
Understanding HOW WE Regulate Software Based Medical Devices
tga
Manufacturing Bacteriophages Products Australia
tga
Manufacturing Supplying AND Advertising Compounded Medicines Lawfully
tga
Corporations ACT 2001
tga
Gene Technology Regulations 2001
tga
Therapeutic Goods Biologicals Specified Things Instrument 2021
tga
Therapeutic Goods Conformity Assessment Standard Quality Management Systems Order 2019
tga
Therapeutic Goods Excluded Goods Determination 2018
tga
Therapeutic Goods Information Specification Database Adverse Event Notifications Instrument 2023
tga
Therapeutic Goods Manufacturing Principles Amendment Determination 2024
tga
Therapeutic Goods Medical Devices Information Must Accompany Application Inclusion Determination 2018
tga
Therapeutic Goods Medical Devices Regulations 2002
tga
Therapeutic Goods Medicines Advisory Statements Specification 2021
tga
Therapeutic Goods Overseas Regulators Determination 2018
tga
Therapeutic Goods Permissible Ingredients Information Must Accompany Application Variation Determination 2023
tga
Therapeutic Goods Standard Disinfectants AND Sanitary Products TGO 104 Order 2019
tga
Therapeutic Goods Standard Faecal Microbiota Transplant Products TGO 105 Order 2020
tga
Therapeutic Goods Standard Medicinal Cannabis TGO 93 Order 2017
tga
Therapeutic Goods Standards Biologicals General AND Specific Requirements TGO 109 Order 2021
tga
Therapeutic Goods Standard Therapeutic Vaping Goods TGO 110 Order 2021
tga
Therapeutic Goods Therapeutic Goods Advertising Code Instrument 2021
tga
Therapeutic Goods Amendment 2020 Measures NO 1 ACT 2020
tga
Therapeutic Goods Order NO 91 Standard Labels Prescription AND Related Medicines
tga
Therapeutic Goods Order NO 92 Standard Labels NON Prescription Medicines
tga
Therapeutic Goods Order NO 95 Child Resistant Packaging Requirements Medicines 2017 TGO 95
tga
Therapeutic Goods Regulations 1990
tga
Therapeutic Goods Vaping Goods Possession AND Supply Determination 2024
tga
Poisons Standard
tga
Therapeutic Goods Permissible Indications Determination
tga
Therapeutic Goods Listed Medicines Conditions Listing Determination 2022
tga
Customs ACT 1901
tga
Australian Immunisation Register ACT 2015
tga
Therapeutic Goods Adverse Event Management System Sponsors Information Specification 2023
tga
Therapeutic Goods Adverse Events Following Immunisation Information Specification 2021
tga
Therapeutic Goods Advertising Complaints AND Investigations Information Specification 2019
tga
Therapeutic Goods Advisory Committee Meetings Information Specification 2022
tga
Therapeutic Goods Advisory Committees Information Sharing Information Specification 2023
tga
Therapeutic Goods Analysis Adverse Events Following Immunisation Information Specification 2022
tga
Therapeutic Goods Articles ARE NOT Medical Devices Amendment Vaping Declaration 2023
tga
Therapeutic Goods Authorised Supply Amendment SAS Guidance Rules 2024
tga
Therapeutic Goods Biologicals Information Must Accompany Application Inclusion Register Determination July 2018
tga
Therapeutic Goods Biologicals Authorised Supply Rules 2022
tga
Therapeutic Goods Biologicals Conditions Inclusion Register Determination 2018
tga
Therapeutic Goods Breast Implants Information Specification 2019
tga
Therapeutic Goods Clinical Trial Inspections Specification NO 2 2020
tga
Therapeutic Goods Complementary Medicines Information Must Accompany Application Registration Determination 2022
tga
Therapeutic Goods Complementary Medicines Information Must Accompany Application Section 26ae Listing Determination August 2018
tga
Therapeutic Goods Excluded Goods Amendment Sunscreen Determination 2024
tga
Therapeutic Goods Excluded Goods Amendment Vaping Determination 2023
tga
Therapeutic Goods Excluded Goods Amendment Determination 2024
tga
Therapeutic Goods Foreign Countries Determination 2016